Pembrolizumab (Keytruda) for the treatment of advanced renal cell cancer


Pembrolizumab (trade name: Keytruda) has been approved since August 2019 in combination with axitinib for the treatment of advanced renal cell cancer in adults who have not had previous treatment.

Renal cell cancer is the most common type of kidney cancer. It usually goes unnoticed for a long time because symptoms only occur in people with advanced, larger tumors. Symptoms include pain in the kidney area that may radiate into the back, as well as blood in urine. If renal cell cancer has already grown too much or spread to other organs (metastatic tumors), surgery to remove it may no longer be an effective treatment.

When deciding on the most suitable treatment, doctors estimate how fast the kidney tumor will probably progress. This is based on several risk factors, such as whether the patient has anemia, high levels of or certain blood cells, and whether the cancer is already affecting their everyday life. The more risk factors the patient has, the poorer their chances of recovery (): The is described as favorable if they have no risk factors. People who have 1 to 2 risk factors are considered to have an intermediate , and those who have 3 or more risk factors are considered to have a poor .

The aim of treatment with pembrolizumab is to stimulate the immune system to inhibit the growth of the cancer.


Pembrolizumab is given through an infusion (an IV drip) every three weeks, entering the bloodstream directly through a vein. One dose has 200 mg of pembrolizumab. The infusion lasts about 30 minutes each time.

Pembrolizumab is combined with axitinib.

This treatment is stopped if severe side effects occur or if the cancer continues to progress.

Other treatments

The first-line treatment for previously untreated advanced renal cell cancer depends on the patient's :

  • For people who have a favorable or intermediate , the treatment options are either a combination of bevacizumab and interferon alfa-2a or treatment with pazopanib or sunitinib.
  • For people who have a poor , sunitinib or temsirolimus are options.


In 2020, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into the advantages and disadvantages of pembrolizumab in combination with axitinib compared to the standard treatments for advanced renal cell carcinoma in adults who have not yet had any treatment.

More information

This information summarizes the main results of a review produced by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The review was commissioned by the German Federal Joint Committee (G-BA) as part of the “early benefit assessment of medications.” On the basis of the review and the hearings received, the G-BA passed a resolution on the added benefit of pembrolizumab (Keytruda).

Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Pembrolizumab (combination with axitinib, renal cell carcinoma)  – Benefit assessment according to §35a Social Code Book V. Dossier assessment; Commission A19-99. February 27, 2020. (IQWiG reports; Volume 887).

IQWiG health information is written with the aim of helping people understand the advantages and disadvantages of the main treatment options and health care services.

Because IQWiG is a German institute, some of the information provided here is specific to the German health care system. The suitability of any of the described options in an individual case can be determined by talking to a doctor. can provide support for talks with doctors and other medical professionals, but cannot replace them. We do not offer individual consultations.

Our information is based on the results of good-quality studies. It is written by a team of health care professionals, scientists and editors, and reviewed by external experts. You can find a detailed description of how our health information is produced and updated in our methods.

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Created on April 23, 2020
Next planned update: 2023


Institute for Quality and Efficiency in Health Care (IQWiG, Germany)

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